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NCT03047967
Effects of Prenatal Tobacco Smoke Exposure on Lung Function and Respiratory Epithelium Functionality in Newborns
NA trial testing lung function tests in Pregnancy Related in 1 participant. Completed in 9 February 2019.
9 February 2018
Quick facts
| Lead sponsor | Institut National de la Santé Et de la Recherche Médicale, France |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 1 |
| Start date | 10 November 2017 |
| Primary completion | 9 February 2018 |
| Estimated completion | 9 February 2019 |
| Sites | 1 location across France |
Drugs / interventions tested
- lung function tests
- Nasal brushing
Conditions studied
- Pregnancy Related — all drugs for Pregnancy Related →
- Tobacco Smoking — all drugs for Tobacco Smoking →
- Lung Smokers — all drugs for Lung Smokers →
- Newborn — all drugs for Newborn →
Sponsor
Institut National de la Santé Et de la Recherche Médicale, France — full company profile →
Who can join
Adults 2 Days to 6 Days, any sex, with Pregnancy Related or Tobacco Smoking. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Despite public campaigns to prevent cigarette smoking, it's about 20% of women who keep on smoking during pregnancy, exposing their fetus to prenatal tobacco adverse effects. Although environnemental tobacco smoke exposure effects are well known, consequences of prenatal tobacco smoke exposure (PTSE) need better caracterization. Previous animal study from our group have shown, in prenatal nicotine exposed mouse pups, alterations in tracheal epithelial structure similar to those observed in KO α7-nAChR mouse pups. These findings support the hypothesis that α7-nAChR are involved in the process of deleterious effects of tobacco smoking on respiratory epithelium development. The purpose of the present clinical study is to compare PTSE neonates with controls according to lung function and respiratory epithelial functionality. At the age of 3 days, small respiratory epithelium fragments will be obtained from gentle nasal brushing performed under antalgic premedication according to the method we previously published. Epithelium samples will be used for in vitro studies of α7-nAChR and CFTR functionality. Between the ages of 2 and 6 weeks, lung function testing will be performed, by means of baby-body plethysmography.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03047967
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03047967 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Institut National de la Santé Et de la Recherche Médicale, France
- Last refreshed: 20 February 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03047967.
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